QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID Continue reading QIDP, a Liberal Hand-Out from FDA

TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

AZD-0914: A New Broad-Spectrum Narrow-Development Path Drug

At first glance, the list of features that distinguish AZD-0914 from other FQ seems impressive: broad Gram-positive and Gram-negative activity, MRSA and MSSA activity, potency against fluoroquinolone (FQ)-resistant isolates, low frequency for S. aureus resistance, and impressive activity against C. Continue reading AZD-0914: A New Broad-Spectrum Narrow-Development Path Drug

Overcoming Antimicrobial Resistance – A European Report Recommends Deja-Vu Action

Sometimes one comes across a particularly well-written policy document which summarizes the status quo of antimicrobial resistance by connecting and synthesizing data from all kinds of sources into a coherent framework. The 2015 OECD Report on Antimicrobial Resistance in G7 Continue reading Overcoming Antimicrobial Resistance – A European Report Recommends Deja-Vu Action

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Roche’s current Phase 2 program is strangely ambiguous.  RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed.  An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game

Fluoroquinolones (FQ) of the ofloxacin/ciprofloxacin generation were mainly active against Gram-negative bacteria, distinguishing themselves as cidal IV/PO drugs with high potency against most lactose- and non-lactose fermenters.  They were excellent against problem pathogens like P. aeruginosa, had excellent efficacy against Salmonellae, the Gonococcus Continue reading MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

Vancomycin vs TMP/SMX for MRSA – Not the Final Word

Vancomycin got a bad reputation since the early 90ies when it became clear that it was slow to provide clinical improvement and microbiologic cure in MRSA patients.  It was associated with prolonged bacteremia even when combined with rifampin [1].  And for MSSA, Continue reading Vancomycin vs TMP/SMX for MRSA – Not the Final Word

No Such Thing as a Free Ride…

..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…

A Renaissance for Old Drugs: Fosfomycin and Colistin

Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin

Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums.  Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

The treatment history of N. gonorrhoeae makes for fascinating reading.  This organism has always been able to keep the upper hand in the war of bug versus drug.  Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially Continue reading A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3

The pleuromutilins are a relatively ‘old’ class of antibiotics that have seen much use in veterinary but not in human medicine.  According to EMA, Tiamulin is an “essential antibiotic” for the control of dysentery in pigs which is caused by Continue reading BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3